Mouth seal assembly for nasal mask system

ABSTRACT

A mouth seal assembly for use with a nasal mask system includes a mouth seal adapted to form a seal with the patient&#39;s mouth. The mouth seal is substantially independent from a supply of pressurized air from the nasal mask system. An anti-asphyxia valve may be provided to either the mouth seal over the patient&#39;s lips or the nasal mask system. A strap arrangement may support the mouth seal in a desired position on the patient&#39;s face in use.

CROSS-REFERENCE TO PRIORITY APPLICATION

This application is a divisional of U.S. application Ser. No.11/988,931, filed Jan. 17, 2008, which is a U.S. national phase ofInternational Application No. PCT/AU2006/001246, filed Aug. 28, 2006,which designated the U.S. and claims the benefit to U.S. ProvisionalApplication No. 60/711,669, filed Aug. 29, 2005, the entire contents ofeach of which are hereby incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to a mouth seal assembly for use with anasal mask system for Non-invasive Positive Pressure Ventilation (NIPPV)and for continuous positive airway pressure (CPAP) therapy of sleepdisordered breathing (SDB) conditions such as obstructive sleep apnea(OSA).

BACKGROUND OF THE INVENTION

Treatment of sleep disordered breathing (SDB), such as obstructive sleepapnea (OSA), by continuous positive airway pressure (CPAP) mask systemsinvolves the continuous delivery of air (or other breathable gas)pressurized above atmospheric pressure to the airways of a human orother mammalian patient via a conduit and a mask. Typically, the maskfits over the nose and/or mouth of the patient. Pressurized air flows tothe mask and to the airways of the patient via the nose and/or mouth. Asthe patient exhales, carbon dioxide gas may collect in the mask. Awashout vent in the mask or conduit discharges the exhaled gas from themask atmosphere.

When nasal mask systems are used, e.g., nasal masks or nozzleassemblies, some patients have a tendency for mouth leak. Alternatively,some patients may have a tendency for mouth breathing when using a nasalmask system. When air escapes through the patient's mouth, the patientdoes not obtain the full benefit of the delivered treatment pressure.Therefore, the effectiveness of CPAP therapy is diminished. In addition,mouth leak may result in noise, increased treatment pressure tocompensate for the leak, increased load on the nasal passages, nasalobstruction, and/or runny nose, for example. The reduction of mouth leakand the prevention of mouth breathing encourage nasal breathing whichmay prove beneficial for the patient.

PCT Application No. PCT/AU2004/001832 and U.S. Pat. Nos. 1,873,160,5,560,354, 6,123,082, and 6,571,798 disclose devices that attempt toreduce mouth leak.

SUMMARY OF THE INVENTION

One aspect of the invention relates to a mouth seal assembly for usewith a nasal mask system that eliminates or at least minimizes mouthleak.

Another aspect of the invention relates to a mouth seal assembly for usewith a nasal mask system that eliminates mouth breathing.

Another aspect of the invention relates to a mouth seal assembly for usewith a nasal mask system. The mouth seal assembly includes a mouth sealadapted to form a seal with the patient's mouth. The mouth seal issubstantially independent from a supply of pressurized air from thenasal mask system. An anti-asphyxia valve is provided to the mouth sealover the patient's lips.

Yet another aspect of the invention relates to a nasal mask systemincluding a nasal mask structured to form a seal with the patient's noseand deliver a supply of pressurized air and a mouth seal assemblyattached to the nasal mask. The mouth seal assembly includes a mouthseal adapted to form a seal with the patient's mouth. The mouth seal issubstantially independent from the supply of pressurized air. Ananti-asphyxia valve is provided to the mouth seal over the patient'slips.

Still another aspect of the invention relates to a mouth seal assemblyfor use with a nasal mask system. The mouth seal assembly includes asubstantially rigid tube adapted to form a seal with the patient's lips.The tube is substantially independent from a supply of pressurized airfrom the nasal mask system. A strap arrangement supports the tube in adesired position on the patient's face in use.

Still another aspect of the invention relates to a nasal mask systemincluding a nasal mask structured to form a seal with the patient's noseand deliver a supply of pressurized air and a mouth seal adapted to forma seal with the patient's mouth. The nasal mask includes a nasalassembly structured to sealingly communicate with nasal passages of thepatient's nose in use and headgear provided to the nasal assembly tomaintain the nasal assembly in a desired position on the patient's face.The mouth seal is substantially independent from the supply ofpressurized air. The nasal assembly and/or headgear supports the mouthseal in position on the patient's face.

Still another aspect of the invention relates to a mouth seal assemblyfor use with a nasal mask system. The mouth seal assembly includes amouth seal adapted to form a seal with the patient's mouth and a mountprovided to the mouth seal and adapted to support the mouth seal on thenasal mask system. The mouth seal is substantially independent from asupply of pressurized air from the nasal mask system. The mouth seal isformed with foam to provide a foam seal or interface with the patient'smouth in use.

Still another aspect of the invention relates to a nasal mask systemincluding a nasal mask structured to form a seal with the patient's noseand deliver a supply of pressurized air and a mouth seal assemblyprovided to the nasal mask. The mouth seal assembly includes a mouthseal adapted to form a seal with the patient's mouth and a mount adaptedto support the mouth seal on the nasal mask. The mouth seal includes abellows or gusset arrangement that provides the mouth seal with asealing force onto the patient's mouth in use.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 is a side view of a mouth seal assembly according to anembodiment of the present invention;

FIG. 2 is a front view of the mouth seal assembly shown in FIG. 1;

FIG. 3 is a side view of the mouth seal assembly shown in FIG. 1 beingused in conjunction with a nasal mask system;

FIG. 4 is a front view of the mouth seal assembly and nasal mask systemshown in FIG. 3;

FIG. 5 is a side view of a mouth seal assembly according to anotherembodiment of the present invention;

FIG. 6 is a front view of the mouth seal assembly shown in FIG. 5;

FIG. 7 is a perspective view of a mouth seal assembly according toanother embodiment of the present invention, the mouth seal assemblybeing used in conjunction with a nasal mask system;

FIG. 8 is a side view of the mouth seal assembly and nasal mask systemshown in FIG. 7;

FIG. 9 is a top view of the mouth seal assembly shown in FIG. 7 isolatedfrom the nasal mask system;

FIG. 10 is a rear view of the mouth seal assembly shown in FIG. 7isolated from the nasal mask system;

FIG. 11 is a perspective view of a mouth seal assembly according toanother embodiment of the present invention, the mouth seal assemblybeing used in conjunction with a nasal mask system;

FIG. 12 is a side view of a mouth seal assembly according to yet anotherembodiment of the present invention, the mouth seal assembly being usedin conjunction with a nasal mask system;

FIG. 13 is a side view of the mouth seal assembly and nasal mask systemshown in FIG. 12 removed from the patient's head;

FIG. 14 is a rear view of the mouth seal assembly and nasal mask systemshown in FIG. 12 removed from the patient's head;

FIG. 15 is a perspective view of a mouth seal assembly according tostill another embodiment of the present invention, the mouth sealassembly being used in conjunction with a nasal mask system;

FIG. 16 is a side view of the mouth seal assembly and nasal mask systemshown in FIG. 15;

FIGS. 17-20 are various views of a mouth seal assembly according toanother embodiment of the present invention, the mouth seal assemblybeing used in conjunction with a nasal mask system;

FIGS. 21-23 are various views of a mouth seal assembly according toanother embodiment of the present invention, the mouth seal assemblybeing used in conjunction with a nasal mask system;

FIG. 24 is a side view of a mouth seal assembly according to anotherembodiment of the present invention, the mouth seal assembly being usedin conjunction with a nasal mask system;

FIG. 25 is a side view of a mouth seal according to another embodimentof the present invention; and

FIGS. 26-30 are top views of mouth seals according to alternativeembodiments of the present invention.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The following includes descriptions of several illustrated embodimentsof the present invention, which may share common characteristics andfeatures. It is to be understood that one or more features of any oneembodiment may be combinable with one or more features of the otherembodiments. In addition, each single feature or combination of featuresin any of the embodiments may constitute an additional embodiment.

Embodiments of the invention are directed towards a mouth seal assemblyfor use with a nasal mask system that eliminates or at least minimizesmouth leak and/or mouth breathing. The mouth seal assembly may beretrofit to an existing nasal mask system, e.g., nasal mask, nozzleassembly, nasal assembly, nasal prongs, nasal pillows, nasal cannulae,nasal inserts, nozzles, etc, or the mouth seal assembly may be providedas original equipment along with a nasal mask system. The mouth sealassembly may or may not include an anti-asphyxia valve. Also, the mouthseal assembly may be supported by a strap arrangement and/or mount thatis separate from and/or integrated with the nasal mask system.

While the mouth seal assembly is described as being used in conjunctionwith or as part of a nasal mask system, the mouth seal assembly may beadapted for use with other suitable breathing arrangements. That is, thebreathing arrangements are merely exemplary, and aspects of the presentinvention may be applicable to other breathing arrangements, e.g.,full-face masks.

1. First Embodiment of Mouth Seal Assembly

FIGS. 1 and 2 illustrate a mouth seal assembly 10 according to anembodiment of the present invention. As illustrated, the mouth sealassembly 10 includes a mouth seal 12 adapted to form a seal with thepatient's mouth and a strap arrangement 14 attached to the mouth seal 12to maintain the mouth seal 12 in a desired position on the patient'sface. The mouth seal assembly 10 is intended to be used in conjunctionwith or as a part of a nasal mask system that provides pressurizedbreathable gas to the patient's nose, e.g., nasal passages. In use, themouth seal assembly 10 eliminates or at least minimizes mouth leak inorder to enhance the effectiveness of therapy.

In the illustrated embodiment, the mouth seal 12 includes a flat stripof silicone 16 or similar flexible material. As illustrated, the mouthseal 12 includes a length and height sufficient to completely cover thepatient's mouth. A small ridge 18 may be incorporated into the mouthseal 12 to assist location between the patient's lips. The mouth seal 12is held against the patient's lips by the strap arrangement 14 whichincludes a strap 20 that extends around the back of the patient's neck.Ends of the strap 20 may be attached to the mouth seal 12 in anysuitable manner, e.g., anchors, hook and loop fasteners, etc.

The mouth seal assembly 10 also includes an anti-asphyxia valve 30 thatprovides an air passage to the patient in the absence of pressure. Theanti-asphyxia valve 30 is provided to the mouth seal 12 over thepatient's lips to allow the patient to breathe in freely in the absenceof pressure but prevent exhalation.

In an alternative embodiment, the mouth seal assembly 10 may be usedwithout the anti-asphyxia valve 30. In this embodiment, the patient mayopen his/her mouth to breath when air pressure is not present, e.g., inthe case of a power supply failure. This is possible since a seal isformed by air pressure causing the patient's lips to “bellow”. Thus, theseal is only “activated” when air pressure is present.

The mouth seal assembly 10 differs from a mask in that it is independentfrom the supply of pressurized air. In use, when the patient has atendency for mouth leak, the pressure inside the patient's mouth pushesthe patient's lips against the mouth seal 12. Thus, the patient's lipsconform to the mouth seal 12 due to the differential pressure betweenthe patient's mouth and the outside of the mouth seal 12. Thisarrangement enables an effective mouth seal, thereby eliminating or atleast minimizing the loss of therapy effectiveness resulting from mouthleak.

FIGS. 3 and 4 illustrate the mouth seal assembly 10 being used inconjunction with a nasal mask system. As illustrated, the nasal masksystem includes a nasal mask 50 adapted to form a seal with thepatient's nose, e.g., nasal passages. The nasal mask 50 includes a nasalassembly 60 structured to sealingly communicate with nasal passages ofthe patient's nose in use, and headgear 70 attached to the nasalassembly 60 to maintain the nasal assembly 60 in a desired position onthe patient's face.

The illustrated nasal mask 50 is commercially sold under the name ofSWIFT® by ResMed Ltd. Further details and embodiments of this nasal mask50 are disclosed in U.S. patent application Ser. Nos. 10/781,929, filedFeb. 20, 2004, now U.S. Pat. No. 7,318,437, and Ser. No. 11/101,657,filed Apr. 8, 2005, now U.S. Pat. No. 7,942,150, the entireties of bothbeing incorporated herein by reference. While the mouth seal assembly 10is described as being used in conjunction with a nasal mask of the typedescribed above, it may be implemented into other nasal masks. That is,the nasal mask 50 is merely exemplary, and the mouth seal assembly 10may be used in conjunction with any suitable nasal mask, e.g., nasalassembly, nasal prongs, nasal pillows, nasal cannulae, nasal inserts,nozzles, etc.

In the illustrated embodiment, the mouth seal assembly 10 includes itsown strap arrangement 14 to maintain the mouth seal 12 in a desiredposition. However, the headgear 70 of the nasal mask 50 may be modifiedto hold the mouth seal 12 in place. In this arrangement, a separateadjustment may be provided to adjust the position of the mouth seal 12.It is also possible that the mouth seal 12 may be maintained in positionwithout straps. In an alternative embodiment, the mask may be modifiedto add support to the mouth seal.

2. Second Embodiment of Mouth Seal Assembly

FIGS. 5 and 6 illustrate a mouth seal assembly 210 according to anotherembodiment of the present invention. As illustrated, the mouth sealassembly 210 includes a mouth seal 212 adapted to form a seal with thepatient's mouth and a strap arrangement 214 attached to the mouth seal212 to maintain the mouth seal 212 in a desired position on thepatient's face.

In the illustrated embodiment, the mouth seal 212 includes an inflated,gel-filled, or foam-filled balloon section 216. As illustrated, themouth seal 212 includes a length and height sufficient to completelycover the patient's mouth. The mouth seal 212 is held against thepatient's lips by the strap arrangement 214 which includes a strap 220that extends around the back of the patient's neck. Ends of the strap220 may be attached to the mouth seal 212 in any suitable manner, e.g.,anchors, hook and loop fasteners, etc.

The mouth seal assembly 210 also includes an anti-asphyxia valve 230that provides an air passage to the patient in the absence of pressure.The anti-asphyxia valve 230 is provided to the mouth seal 212 over thepatient's lips to allow the patient to breathe in freely in the absenceof pressure but prevent exhalation.

Similar to the mouth seal assembly 10 described above, the mouth sealassembly 210 is independent from the supply of pressurized air and thepatient's lips conform to the mouth seal 212 due to the differentialpressure between the patient's mouth and the outside of the mouth seal.

In an alternative embodiment, the mouth seal assembly 210 may be usedwithout the anti-asphyxia valve 230. In this embodiment, the patient mayopen his/her mouth to breath when air pressure is not present, e.g., inthe case of a power supply failure. This is possible since a seal isformed by air pressure causing the patient's lips to “bellow”. Thus, theseal is only “activated” when air pressure is present.

In an embodiment, the mouth seal assembly 210 may include a smalllocating ridge such as that described above. In another embodiment, theballoon section 216 may be solid and shaped to fit the patient's lips.

3. Third Embodiment of Mouth Seal Assembly

FIGS. 7-10 illustrate a mouth seal assembly 310 according to anotherembodiment of the present invention. As illustrated in FIGS. 7-8, themouth seal assembly 310 is used in conjunction with a nasal mask 350adapted to form a seal with the patient's nose. The nasal mask 350includes a nasal cushion/frame assembly 360 structured to seal aroundthe patient's nose in use, and headgear 370 attached to the nasalcushion/frame assembly 360 to maintain the nasal cushion/frame assembly360 in a desired position on the patient's face.

The illustrated nasal mask 350 is commercially sold under the name ofMIRAGE® by ResMed Ltd. Further details and embodiments of this nasalmask 350 are disclosed in U.S. Pat. No. 6,112,746, the entirety beingincorporated herein by reference. While the mouth seal assembly 310 isdescribed as being used in conjunction with a nasal mask of the typedescribed above, it may be implemented into other nasal masks. That is,the nasal mask 350 is merely exemplary, and the mouth seal assembly 310may be used in conjunction with any suitable nasal mask, e.g., nasalassembly, nasal prongs, nasal pillows, nasal cannulae, nasal inserts,nozzles, etc.

The mouth seal assembly 310 includes a mouth seal 312 adapted to form aseal with the patient's mouth and a strap arrangement 314 attached tothe mouth seal 312 to maintain the mouth seal 312 in a desired positionon the patient's face. In the illustrated embodiment, the mouth seal 312includes a curved strip of silicone 316 or similar flexible materialthat generally conforms to the curvature of the patient's mouth region(see FIGS. 9 and 10). The mouth seal 312 includes a length and heightsufficient to completely cover the patient's mouth.

The mouth seal assembly 310 also includes an anti-asphyxia valve 330that provides an air passage to the patient in the absence of pressure.The anti-asphyxia valve 330 is provided to the mouth seal 312 over thepatient's lips to allow the patient to breathe in freely in the absenceof pressure but prevent exhalation in the presence of air pressure. Asshown in FIG. 10, a slit 317 is provided in the silicone 316 tocommunicate the anti-asphyxia valve 330 with the patient's mouth.

In an alternative embodiment, the mouth seal assembly 310 may be usedwithout the anti-asphyxia valve 330. In this embodiment, the patient mayopen his/her mouth to breath when air pressure is not present, e.g., inthe case of a power supply failure. This is possible since a seal isformed by air pressure causing the patient's lips to “bellow”. Thus, theseal is only “activated” when air pressure is present.

The mouth seal 312 is held against the patient's lips by the straparrangement 314 which includes a strap 320 that extends along the sidesof the patient's face. At least one end of the strap 320 includes aVELCRO® section 322 that allows the end to adjustably attach to arespective lower strap 372 of the nasal mask headgear 370 (see FIG. 8).However, the strap arrangement 314 may be independent of the nasal maskheadgear 370, e.g., extend around the back of the patient's neck.

In the illustrated embodiment, the strap 320 of the headgear arrangement314 includes an opening 324 adapted to receive the anti-asphyxia valve330 therethrough. The anti-asphyxia valve 330 protrudes from the mouthseal 312 and includes a flange 332 that retains the strap 320 to theanti-asphyxia valve 330 and hence the mouth seal 312. However, the mouthseal 312 may be attached to the headgear arrangement 314 in any othersuitable manner

Similar to the mouth seal assembly 10 described above, the mouth sealassembly 310 is independent from the supply of pressurized air and thepatient's lips conform to the mouth seal 312 due to the differentialpressure between the patient's mouth and the outside of the mouth seal.

4. Fourth Embodiment of Mouth Seal Assembly

FIG. 11 illustrates a mouth seal assembly 410 according to anotherembodiment of the present invention. As illustrated, the mouth sealassembly 410 is used in conjunction with a nasal mask 450 adapted toform a seal with the patient's face. The nasal mask 450 includes a nasalcushion/frame assembly 460 structured to seal around the patient's nosein use, and headgear 470 attached to the nasal cushion/frame assembly460 to maintain the nasal cushion/frame assembly 460 in a desiredposition on the patient's face.

The illustrated nasal mask 450 is commercially sold under the name ofACTIVA® by ResMed Ltd. Further details and embodiments of this nasalmask 450 are disclosed in U.S. patent application Ser. No. 10/655,622,filed Sep. 5, 2003, now U.S. Pat. No. 7,523,754, the entirety beingincorporated herein by reference. While the mouth seal assembly 410 isdescribed as being used in conjunction with a nasal mask of the typedescribed above, it may be implemented into other nasal masks. That is,the nasal mask 450 is merely exemplary, and the mouth seal assembly 410may be used in conjunction with any suitable nasal mask, e.g., nasalassembly, nasal prongs, nasal pillows, nasal cannulae, nasal inserts,nozzles, etc.

The mouth seal assembly 410 includes a mouth seal 412 adapted to form aseal with the patient's mouth. In the illustrated embodiment, the mouthseal 412 includes a strip of silicone 416 or similar flexible materialthat generally conforms to the curvature of the patient's mouth region.The mouth seal 412 includes a length and height sufficient to completelycover the patient's mouth.

The mouth seal assembly 410 also includes an anti-asphyxia valve 430that provides an air passage to the patient in the absence of pressure.The anti-asphyxia valve 430 is provided to the mouth seal 412 over thepatient's lips to allow the patient to breathe in freely in the absenceof pressure but prevent exhalation in the presence of pressure.

In an alternative embodiment, the mouth seal assembly 410 may be usedwithout the anti-asphyxia valve 430. In this embodiment, the patient mayopen his/her mouth to breath when air pressure is not present, e.g., inthe case of a power supply failure. This is possible since a seal isformed by air pressure causing the patient's lips to “bellow”. Thus, theseal is only “activated” when air pressure is present.

In the illustrated embodiment, the mouth seal assembly 410 is attachedto the nasal mask 450. In addition, the headgear 470 of the nasal mask450 is attached to the mouth seal assembly 410 to hold the mouth seal412 against the patient's lips as well as hold a lower portion of thenasal cushion/frame assembly 460 against the patient's nasal region.

Specifically, a support structure 480 is provided to attach the mouthseal assembly 410 to the nasal mask 450. In the illustrated embodiment,the support structure 480 includes an anchor 482 attached to the nasalcushion/frame assembly 460 and a wire arrangement 484 that wraps aroundthe anti-asphyxia valve 430 to connect the mouth seal assembly 410 tothe anchor 482. However, the mouth seal assembly 410 may be attached tothe nasal mask 450 in other suitable manners.

The headgear 470 of the nasal mask 450 includes upper straps 472attached to a forehead support 452 of the nasal mask 450 and lowerstraps 474 that are removably attached to the mouth seal assembly 410.As illustrated, the end of each lower strap 474 includes a clip 476 thatis adapted to engage a respective clip receiver 490 provided to themouth seal assembly 410. The clip receivers 490 are attached to themouth seal assembly by a wire arrangement 492 that wraps around the wirearrangement 484 associated with the nasal mask 450. However, the clipreceivers 490 may be attached to the mask seal assembly 410 in othersuitable manners. In addition, the lower straps 474 may be attached tothe mask seal assembly 410 in other suitable manners.

In use, the upper and lower straps 472, 474 maintain the nasal mask 450and the mouth seal 412 in a desired position on the patient's face. Inanother embodiment, the mouth seal assembly 410 may be independent fromthe nasal mask 450 and a separate strap arrangement may be provided tosecure the mouth seal assembly 410 to the patient's head. In thisarrangement, clips may be provided to the lower straps 474 that areadapted to engage respective clip receivers 454 provided to the nasalcushion/frame assembly 460.

Similar to the mouth seal assembly 10 described above, the mouth sealassembly 410 is independent from the supply of pressurized air and thepatient's lips conform to the mouth seal 412 due to the differentialpressure between the patient's mouth and the outside of the mouth seal.

5. Fifth Embodiment of Mouth Seal Assembly

FIGS. 12-14 illustrate a mouth seal assembly 510 according to anotherembodiment of the present invention. As illustrated, the mouth sealassembly 510 is used in conjunction with an ACTIVA® nasal mask 450. TheACTIVA® nasal mask 450 is indicated with similar reference numerals asdescribed above. While the mouth seal assembly 510 is described as beingused in conjunction with a nasal mask of the type described above, itmay be implemented into other nasal masks. That is, the nasal mask 450is merely exemplary, and the mouth seal assembly 510 may be used inconjunction with any suitable nasal mask, e.g., nasal assembly, nasalprongs, nasal pillows, nasal cannulae, nasal inserts, nozzles, etc.

The mouth seal assembly 510 includes a mouth seal 512 adapted to form aseal with the patient's mouth. In the illustrated embodiment, the mouthseal 512 includes a curved strip of silicone 516 or similar flexiblematerial that generally conforms to the curvature of the patient's mouthregion. The mouth seal 512 includes a length and height sufficient tocompletely cover the patient's mouth.

The mouth seal assembly 510 also includes an anti-asphyxia valve 530that provides an air passage to the patient in the absence of pressure.The anti-asphyxia valve 530 is provided to the mouth seal 512 over thepatient's lips to allow the patient to breathe in freely in the absenceof pressure but prevent exhalation in the presence of pressure. As shownin FIG. 14, a slit 517 is provided in the silicone 516 to communicatethe anti-asphyxia valve 530 with the patient's mouth.

In an alternative embodiment, the mouth seal assembly 510 may be usedwithout the anti-asphyxia valve 530. In this embodiment, the patient mayopen his/her mouth to breath when air pressure is not present, e.g., inthe case of a power supply failure. This is possible since a seal isformed by air pressure causing the patient's lips to “bellow”. Thus, theseal is only “activated” when air pressure is present.

In the illustrated embodiment, the mouth seal assembly 510 is attachedto the nasal mask 450. In addition, the headgear 470 of the nasal mask450 is adapted to hold the mouth seal 512 against the patient's lips aswell as hold a lower portion of the nasal cushion/frame assembly 460against the patient's nasal region.

Specifically, a support structure 580 is provided to attach the mouthseal assembly 510 to the nasal mask 450. In the illustrated embodiment,the support structure 580 includes an anchor 582 attached to the nasalcushion/frame assembly 460 and a wire arrangement 584 that wraps aroundthe anti-asphyxia valve 530 to connect the mouth seal assembly 510 tothe anchor 582. However, the mouth seal assembly 510 may be attached tothe nasal mask 450 in other suitable manners.

The headgear 470 of the nasal mask 450 includes upper straps 472attached to a forehead support 452 of the nasal mask 450 and lowerstraps 474 attached to a lower portion of the nasal cushion/frameassembly 460. Specifically, the end of each lower strap 474 includes aclip 477 that is adapted to be engaged within a respective clip receiver454 provided to the nasal cushion/frame assembly 460. In use, the upperand lower straps 472, 474 maintain the nasal mask 450 and the mouth seal512 in a desired position on the patient's face. In another embodiment,the mouth seal assembly 510 may be independent from the nasal mask 450and a separate strap arrangement may be provided to secure the mouthseal assembly 510 to the patient's head.

Similar to the mouth seal assembly 10 described above, the mouth sealassembly 510 is independent from the supply of pressurized air and thepatient's lips conform to the mouth seal 512 due to the differentialpressure between the patient's mouth and the outside of the mouth seal.

6. Sixth Embodiment of Mouth Seal Assembly

FIGS. 15 and 16 illustrate a mouth seal assembly 610 according toanother embodiment of the present invention. As illustrated, the mouthseal assembly 610 is used in conjunction with an MIRAGE® nasal mask 350.The MIRAGE® nasal mask 350 is indicated with similar reference numeralsas described above. While the mouth seal assembly 610 is described asbeing used in conjunction with a nasal mask of the type described above,it may be implemented into other nasal masks. That is, the nasal mask350 is merely exemplary, and the mouth seal assembly 610 may be used inconjunction with any suitable nasal mask, e.g., nasal assembly, nasalprongs, nasal pillows, nasal cannulae, nasal inserts, nozzles, etc.

The mouth seal assembly 610 includes a mouth seal 612 adapted to form aseal with the patient's mouth and a strap arrangement 614 attached tothe mouth seal 612 to maintain the mouth seal 612 in a desired positionon the patient's face. In the illustrated embodiment, the mouth seal 612includes an elongated substantially rigid tube 616 that sits on thepatient's lips. The tube 616 may have a solid or hollow configuration,and includes a length sufficient to extend along the patient's lips.

The tube 616 is held against the patient's lips by the strap arrangement614 which includes side straps 620 that extend along the sides of thepatient's face. One end of each strap 620 is attached to a respectiveend of the tube 616, e.g., by hook mechanism, and the opposing end ofeach strap 620 is attached to a respective lower strap 372 of the nasalmask headgear 370, e.g., by a clip mechanism, hook and loop fasteners,etc. However, the strap arrangement 614 may be independent of the nasalmask headgear 370, e.g., extend around the back of the patient's neck.

The tube 616 is independent from the supply of pressurized air. The tube616 provides a surface upon which the patient's lips are pushed due tomouth leak and thus form a seal. This mechanism provides a seal that is“activated” when pressure is applied to the mask, however in the eventof power failure or lack or pressure, the seal is not “activated” andthus the patient can open his/her mouth to breath.

7. Seventh Embodiment of Mouth Seal Assembly

FIGS. 17 to 20 illustrate a mouth seal assembly 710 according to anotherembodiment of the present invention. As illustrated, the mouth sealassembly 710 is used in conjunction with a SWIFT® nasal mask 50. TheSWIFT® nasal mask 50 is indicated with similar reference numerals asdescribed above. While the mouth seal assembly 710 is described as beingused in conjunction with a nasal mask of the type described above, itmay be implemented into other nasal masks. That is, the nasal mask 50 ismerely exemplary, and the mouth seal assembly 710 may be used inconjunction with any suitable nasal mask.

The mouth seal assembly 710 includes a mouth seal 712 adapted to form aseal with the patient's mouth. In the illustrated embodiment, the mouthseal 712 includes a curved strip of silicone 716 or similar flexiblematerial that generally conforms to the curvature of the patient's mouthregion (e.g., see FIG. 17). The mouth seal 712 includes a length andheight sufficient to completely cover the patient's mouth. FIGS. 19 and20 illustrate transparent and solid views of the mouth seal 712 to showthe mouth seal 712 in relation to the patient's mouth.

In the illustrated embodiment, the mouth seal 712 is maintained in adesired position by the headgear 70 and/or the nasal assembly 60 of thenasal mask 50. The headgear 70 and/or nasal assembly 60 may be modifiedto support the mouth seal 712 in place. Thus, the mouth seal 712 ismaintained in position without its own strap arrangement. However, themouth seal 712 may be supported in other suitable manners.

Similar to the mouth seal assembly 10 described above, the mouth sealassembly 710 is independent from the supply of pressurized air and thepatient's lips conform to the mouth seal 712 due to the differentialpressure between the patient's mouth and the outside of the mouth seal.The mouth seal 712 may be provided with or without an anti-asphyxiavalve.

8. Eighth Embodiment of Mouth Seal Assembly

FIGS. 21 to 23 illustrate a mouth seal assembly 810 according to anotherembodiment of the present invention. As illustrated, the mouth sealassembly 810 is used in conjunction with an ACTIVA® nasal mask 450. TheACTIVA® nasal mask 450 is indicated with similar reference numerals asdescribed above. While the mouth seal assembly 810 is described as beingused in conjunction with a nasal mask of the type described above, itmay be implemented into other nasal masks. That is, the nasal mask 450is merely exemplary, and the mouth seal assembly 810 may be used inconjunction with any suitable nasal mask, e.g., nasal assembly, nasalprongs, nasal pillows, nasal cannulae, nasal inserts, nozzles, etc.

The mouth seal assembly 810 includes a mouth seal 812 adapted to form aseal with the patient's mouth and a support structure or mount 880 tosupport the mouth seal 812 on the nasal mask 450. In the illustratedembodiment, the mouth seal 812 is formed with foam, e.g., foam-filledcylinder or strip, and provides a foam seal or interface with thepatient's mouth. The foam mouth seal 812 includes a length and heightsufficient to completely cover the patient's mouth. In an alternativeembodiment, the foam mouth seal 812 may be shaped to better fit thefacial profile around the patient's lips, e.g., see FIG. 25 describedbelow.

The foam mouth seal 812 provides a compliant seal that comfortablyengages the patient's mouth. The compliant nature of the foam ensuresthat it deforms to seal against a range of facial profiles. That is, thefoam can deform to the appropriate size and shape without compromisingthe seal and without adding discomfort to the patient.

When the nasal mask 450 is pressurized, the patients lips will “bellow”to engage the foam mouth seal 812 and form a seal that substantiallyprevents mouth leak and mouth breathing. If the nasal mask 450 is notpressurized, e.g., in the case of a power supply failure, the foam mouthseal 812 is not “activated” and the patient is free to open his/hermouth to breathe. In an alternative embodiment, an anti-asphyxia valvemay be provided to the mouth seal or the air supply to the mask. Also,the mouth seal 812 may alternatively be filled with gel, silicone, orair to provide a similar compliant seal.

The support structure or mount 880 is preferably lightweight and may beconstructed of a polycarbonate or steel material, for example. Thesupport structure 880 may be mounted to the nasal mask and mouth seal812 in any suitable manner In an embodiment, the support structure 880may be biased, e.g., spring biased, to provide the mouth seal 812 with asealing force onto the patient's mouth. However, the mouth seal 812 maybe attached to the nasal mask 450 in other suitable manners. Forexample, existing structures on the nasal mask may be used to supportthe mouth seal. In an embodiment, the mount may be supported by one ormore ports typically provided on nasal masks (and typically closed by aports cap). In another embodiment, the mount may be supported byheadgear clips associated with the nasal mask headgear. The headgearclip may be modified to incorporate the mount.

Similar to the mouth seal assembly 10 described above, the mouth sealassembly 810 is independent from the supply of pressurized air and thepatient's lips conform to the mouth seal 812 due to the differentialpressure between the patient's mouth and the outside of the mouth seal.

9. Ninth Embodiment of Mouth Seal Assembly

FIG. 24 illustrates a mouth seal assembly 910 according to anotherembodiment of the present invention. As illustrated, the mouth sealassembly 910 is used in conjunction with an ACTIVA® nasal mask 450. TheACTIVA® nasal mask 450 is indicated with similar reference numerals asdescribed above. While the mouth seal assembly 910 is described as beingused in conjunction with a nasal mask of the type described above, itmay be implemented into other nasal masks. That is, the nasal mask 450is merely exemplary, and the mouth seal assembly 910 may be used inconjunction with any suitable nasal mask, e.g., nasal assembly, nasalprongs, nasal pillows, nasal cannulae, nasal inserts, nozzles, etc.

The mouth seal assembly 910 includes a mouth seal 912 adapted to form aseal with the patient's mouth and a support structure or mount 980 tosupport the mouth seal 912 on the nasal mask 450. In the illustratedembodiment, the mouth seal 912 is formed with foam, e.g., foam-filledcylinder or strip, and provides a foam seal or interface with thepatient's mouth. Similar to mouth seal 812 described above, the foammouth seal 912 provides a compliant seal that comfortably engages thepatient's mouth. In alternative embodiments, the mouth seal 912 may befilled with gel, silicone, or air to provide a similar compliant seal.

As shown in FIG. 25, the foam mouth seal 912 may be shaped to better fitthe facial profile around the patient's lips. In use, the patient's lipswould fit within the space 913 provided between upper and lowerprotrusions 916, 918 of the foam mouth seal 912.

The support structure or mount 980 is preferably lightweight and may beconstructed of a polycarbonate or steel material, for example. Thesupport structure 980 may be mounted to the nasal mask and mouth seal912 in any suitable manner In an embodiment, the support structure 980may be biased, e.g., constructed of spring steel with a spring bias, toprovide the mouth seal 912 with a sealing force onto the patient'smouth. However, the mouth seal 912 may be attached to the nasal mask 450in other suitable manners.

Similar to the mouth seal assembly 10 described above, the mouth sealassembly 910 is independent from the supply of pressurized air and thepatient's lips conform to the mouth seal 912 due to the differentialpressure between the patient's mouth and the outside of the mouth seal.The mouth seal 912 may be provided with or without an anti-asphyxiavalve.

10. Alternative Embodiments of Mouth Seal

FIGS. 26-30 illustrate mouth seals according to alternative embodimentsof the present invention. Each mouth seal may be used in conjunctionwith a nasal mask such as the SWIFT®, MIRAGE®, and ACTIVA® nasal masks50, 350, 450 described above.

FIG. 26 illustrates a mouth seal 1012 formed with foam, e.g.,foam-filled cylinder or strip, that provides a foam seal or interfacewith the patient's mouth. A mount 1080 is provided to the mouth seal1012 to support the mouth seal 1012 on a nasal mask. The foam mouth seal1012 is similar to the foam mouth seals 812, 912 described above.

FIG. 27 illustrates a mouth seal 1112 formed with foam, e.g.,foam-filled cylinder or strip, that provides a foam seal or interfacewith the patient's mouth. A mount 1180 is provided to the mouth seal1112 to support the mouth seal 1112 on a nasal mask. As illustrated, themouth seal 1112 is shaped to fit the facial contours or profile of thepatient's face.

FIG. 28 illustrates a mouth seal 1212 formed with foam, e.g.,foam-filled cylinder or strip, that provides a foam seal or interfacewith the patient's mouth. A mount 1280 is provided to the mouth seal1212 to support the mouth seal 1212 on a nasal mask. As illustrated, aspring arrangement 1290, e.g., a plurality of coil springs 1292, isprovided between the mount 1280 and the mouth seal 1212 to provide themouth seal 1212 with a sealing force onto the patient's mouth. Thesealing force provided by the spring arrangement 1290 will be opposed tothe force of the air within the patient's mouth pressing against thelips.

However, the sealing force may be generated by other suitablearrangements. For example, FIG. 29 illustrates a mouth seal 1312including a concertina or bellows arrangement. A mount 1380 is providedto the mouth seal 1312 to support the mouth seal 1312 on a nasal mask.The plurality of bellows 1313 of the mouth seal 1312 provide the mouthseal 1312 with a sealing force onto the patient's mouth.

FIG. 30 illustrates a mouth seal 1412 including a gusset arrangement. Amount 1480 is provided to the mouth seal 1412 to support the mouth seal1412 on a nasal mask. In use, pressurized air from the nasal mask isprovided to the gusseted mouth seal 1412, e.g., via the mount 1480, toexpand the gusseted mouth seal 1412 and provide a sealing force onto thepatient's mouth.

In each of the above-described embodiments, the mouth sealing assembly10, 210, 310, 410, 510, 610, 710, 810, 910 may be used as an optionalcomponent of a nasal mask system. That is, the mouth sealing assemblymay be optionally used in conjunction with a nasal mask system toeliminate or at least minimize mouth leak in order to enhance theeffectiveness of therapy.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. In addition, while the invention hasparticular application to patients who suffer from OSA, it is to beappreciated that patients who suffer from other illnesses (e.g.,congestive heart failure, diabetes, morbid obesity, stroke, barriatricsurgery, etc.) can derive benefit from the above teachings. Moreover,the above teachings have applicability with patients and non-patientsalike in non-medical applications.

1. A mouth seal assembly for use with a nasal mask system, comprising: amouth seal adapted to form a seal with the mouth of a patient, the mouthseal being substantially independent from a supply of pressurized airfrom the nasal mask system; and a mount provided to the mouth seal andadapted to support the mouth seal on the nasal mask system, wherein themouth seal is formed with foam to provide a foam mouth seal with thepatient's mouth in use.
 2. The mouth seal assembly according to claim 1,wherein the foam mouth seal includes a foam-filled cylinder or strip. 3.The mouth seal assembly according to claim 1, further comprising ananti-asphyxia valve provided to the mouth seal over the patient's lips.4. The mouth seal assembly according to claim 1, wherein the mount isbiased to provide the mouth seal with a sealing force onto the patient'smouth.
 5. The mouth seal assembly according to claim 4, furthercomprising a spring arrangement between the mount and the mouth seal toprovide the mouth seal with the sealing force.
 6. The mouth sealassembly according to claim 1, wherein the mouth seal is shaped orcontoured to fit a facial profile around the patient's lips.
 7. Themouth seal assembly according to claim 6, wherein the mouth sealincludes upper and lower protrusions that define a space adapted to fitthe patient's lips in use.
 8. A nasal mask system comprising: a nasalmask structured to form a seal with the nose of a patient and deliver asupply of pressurized air; and a mouth seal assembly according toclaim
 1. 9. The mouth seal assembly according to claim 1, wherein thefoam mouth seal is shaped to better fit the facial profile around thepatient's lips.
 10. The mouth seal assembly according to claim 1,wherein the mouth seal is adapted to form the seal with the patient'smouth when the patient's lips bellow outward due to pressurized air fromthe nasal mask system entering the patient's mouth.
 11. The mouth sealassembly according to claim 1, wherein the mount is supported by one ormore ports provided on the nasal mask system.
 12. The mouth sealassembly according to claim 1, wherein the mount is supported by one ormore headgear clips associated with headgear of the nasal mask system.13. A method of sealing the mouth of a patient, comprising: placing amouth seal external to the mouth such that the mouth seal is not in asealing relationship with the mouth; providing pressurized breathablegas to the patient using a nasal mask system; and activating a sealbetween the patient's mouth and the mouth seal using the pressurizedbreathable gas.
 14. The method of sealing the mouth of the patientaccording to claim 13, wherein the seal is activated by moving thepatient's lips into sealing contact with the mouth seal by using thepressurized breathable gas.
 15. The method of sealing the mouth of thepatient according to claim 13, wherein the seal between the patient'smouth and the mouth seal is activated by mouth leak.
 16. The method ofsealing the mouth of the patient according to claim 13, wherein the sealbetween the patient's mouth and the mouth seal is activated by adifferential pressure between the mouth and ambient.
 17. The method ofsealing the mouth of the patient according to claim 16, wherein thedifferential pressure causes the patient's lips to bellow into contactwith the mouth seal.
 18. The method of sealing the mouth of the patientaccording to claim 13, wherein the mouth seal comprises a substantiallyflat strip of material located external to and adjacent to the patient'slips.
 19. The method of sealing the mouth of the patient according toclaim 13, further comprising maintaining the mouth seal in place with astrap arrangement before and after the seal is activated.
 20. The methodof sealing the mouth of the patient according to claim 13, furthercomprising eliminating mouth leak as a result of the seal beingactivated.
 21. The method of sealing the mouth of the patient accordingto claim 13, further comprising completely covering the mouth with themouth seal.
 22. The method of sealing the mouth of the patient accordingto claim 13, further comprising locating the mouth seal with a ridge onthe mouth seal by placing the ridge between the patient's lips.
 23. Themethod of sealing the mouth of the patient according to claim 13,further comprising sealing an anti-asphyxia valve in the mouth seal withthe pressurized breathable gas.
 24. The method of sealing the mouth ofthe patient according to claim 13, further comprising removing thepressurized breathable gas and allowing the patient to breathe freelythough the mouth without having moved the mouth seal.